CN103987416A - Recycled resin compositions and disposable medical devices made therefrom - Google Patents

Abstract

Syringe plunger rods are described. The syringe plunger rods comprise an elongate body formed from a composition comprising one or more of virgin material, a sterilization-stable recycled resin and a biobased compositions. Plunger rods comprising a plurality of ribs, some of which may have a plurality of openings, are also described. The plunger rods require less material while maintain sufficient structural integrity to function properly.

Description

Recycled resin compositions and by the disposable medical equipment of its manufacture

Background

The present invention relates to recycled resin compositions, the medical device being formed by new material or recycled resin compositions and for prepare the method for medical device from new material or recycled resin compositions.Particularly, embodiments of the present invention are for the syringe plunger rod by new material, recycled resin compositions, bio-based materials or its combination preparation, and it needs less material to keep the structural intergrity that suitable operation is enough simultaneously.

Plastics form disposable medical equipment, non-once medical device, medical device packaging and comprise the significant proportion in other non-medical device application major parts of automobile and article of everyday use.These for example comprise the especially polymer of polypropylene, polyethylene, polystyrene, polyethylene terephthalate and Merlon.Past many decades increases the exhaustion that the use of plastics has been caused to the growing impact for garbage loading embeading ability and fossil fuel resource.In addition, refuse also can be incinerated, and produces thus potential air pollution problems inherent.What day by day increase has also caused to the use of plastics the Environmental Degradation, the carbon emission amount of following and other environmental effects that increase.

Consider the problems referred to above, the recirculation thermoplastic polymeric material's that growing interest can obtain from multiple source use.Drive using recirculation thermoplastic polymeric material's growing interest to be subject to many factors; comprise the class client of mechanism that the increase of the vigilance of consumer to environmental conservation and concern, Environment Priority purchase policy that consumer forms, the brand owner and can the sell goods understanding to environmental management benefit on market itself, be intended to reduce the new regulations of carbon emission amount and the development of environmental policy and be accompanied by for the storage of stricter regulations of disposing and incinerate and/or the hope of the growing cost of landfill space reducing.The ability that uses the growing interest of recirculation thermoplastic polymeric material and thermosets to be also subject to recirculation practitioner constantly to manufacture the raising of the recycled resin of high-quality is driven.These factors have caused in automobile and packaging for foodstuff application and have been widely used recycled plastic.For example, Ford Motor Company has has researched and developed the method that increases the use of recycled materials in its vehicle production.Two exemplary results of these research and development comprise that fragment is recycled to automobile air purifier by recirculation and the E.I.du Pont de Nemours and Company of the thermoplasticity fragment from bumper of Visteon Automotive Systems.The PET of recirculation or polyethylene terephthalate are widely used in food and comprise in the packaging applications of carafe.

For reducing the impact to garbage loading embeading the sacrificing security not in the situation that when, improve the environmental management of medical device and health institution and meet the ability of environmental goals, for example LEED system, focuses on manufacturing the medical device of being made up of recycled plastic gradually.For the potential problems that use recycled resin in the manufacture of medical device or its assembly comprise for example lack biocompatibility, batch between character change and the obstacle of apparent undesirable change during sterilization process.In addition, when by recycled resin compositions when forming stream contact medical device, concern be that between recycled resin compositions may have batch, character changes, pollutes, maybe may be subject to the interference via the material of medical device conveying, carrying or transmission.

Therefore, industrially need to comprise biocompatible, that sterilizing is stable and apply useful recycled resin compositions for medical device thermoplastic compounds.Such recycled resin compositions is not limited to medical device application and will be applicable to use any industry of the stable this compositions of sterilizing.

Summary of the invention

One or more embodiment of the present invention relates to syringe plunger rod, and it comprises: main body, finger pressure (thrumpress) and the stopper eyelid retractor (stopper support) of elongation.The main body of extending has near-end and the far-end of definition length, and the main body of elongation is by comprising that one or more the compositions in recycled resin and the bio-based compositions that sterilizing is stable forms.Finger pressure is positioned at the near-end of the main body of elongation, and stopper eyelid retractor is positioned at the far-end of the main body of elongation.

In some embodiments, the main body of described elongation comprises that at least one extends the rib of the length of the main body of described elongation, and described at least one rib comprises the opening at multiple intervals.In detailed embodiment, the main body of elongation comprises the rib of four plus sige shapes.In concrete embodiment, the opening at multiple intervals is along two in four ribs.

In detailed embodiment, the main body of described elongation comprises three ribs.In concrete embodiment, the opening at multiple intervals is along two in three ribs.In specific embodiment, the opening at multiple intervals is along one in three ribs.In some embodiments, the main body of elongation comprises at least two ribs of length that extend the main body of described elongations, and the opening at described multiple intervals is positioned at and is less than on whole ribs.

In detailed embodiment, the main body of described elongation comprises the rib of two V-arrangements and the multiple supporting walls along the length interval of the main body of described elongation.

Some way of example further comprise the supporting walls at the length interval of multiple main bodys along extending.

In one or more embodiments, the main body of elongation comprises hollow bulb.Concrete embodiment further comprises at least one rib extending along the length of the main body of described elongation at least in part that is positioned at described hollow bulb.In detailed embodiment, described hollow bulb is configured as the shape of the main body that is substantially similar to described elongation.

In detailed embodiment, syringe plunger rod can be born and be comprised: be exposed to about 5kGys in the gamma-rays of about 75kGys, be exposed to about 40kGys in the electron beam of about 100kGys, be exposed in X-radiation, be exposed to one or more the sterilizing in the sterilizing of ethylene oxide gas middle high-pressure and plasma sterilization.In concrete embodiment, compositions comprises following recycled resin compositions, it has approximately 0.1% recycled resin to approximately 100 % by weight, and described recycled resin is selected from the one of industrial rear recycled resin, the rear recycled resin of consumption and its combination.In specific embodiment, described compositions further comprises one or more in following component: filler component, surface modifier component, processing aid component, melt stability agent, clarifier and enhancer component are covered in antioxidant ingredients, slip agent component, antistatic component, anti-impact modifier component, coloring agent component, plumper component, x-ray fluorescence agent component, radiation.

It is identical with the plunger rod being formed by non-recycled resin compositions or than its better functional characteristic that the syringe plunger rod of some embodiments demonstrates.In detailed embodiment, described compositions has the flexural modulus of about 70kpsi to about 300kpsi.In concrete embodiment, described compositions has the melt flow index of about 3dg/ minute to about 80dg/ minute.In specific embodiment, described compositions has the heat distortion temperature of approximately 68 DEG C to approximately 140 DEG C.In one or more embodiments, described compositions has the notched Izod impact strength of about 0.2ft-lb/in to about 3.0ft-lb/in.

In some embodiments, the main body of described elongation is cylindrical and has the multiple main body of elongation, openings along the length interval of described elongation main body of running through.

Another embodiment of the present invention relates to syringe plunger rod, and it comprises main body, finger pressure and the stopper eyelid retractor of elongation.The main body of extending has near-end and the far-end of definition length.The main body of described elongation has at least one opening that runs through it.Finger pressure is arranged on the near-end of the main body of elongation, and stopper eyelid retractor is arranged on the far-end of the main body of elongation.Described plunger rod is made up of one or more the compositions that containing in new material, sterilizing stable recycled resin and bio-based compositions.

In some embodiments, the main body of described elongation comprise the main body of extending this elongation length at least one rib and along multiple openings at the length interval of described at least one rib.In detailed embodiment, the main body of described elongation comprises along the hollow bulb of the principal length of this elongation.Concrete embodiment further comprises and is positioned at described hollow bulb, at least one rib extending along at least part of length of the main body of described elongation.

Brief description of the drawings

Fig. 1 represents the exploded view of the injector assembly of the one or more embodiments of the present invention.

Fig. 2 represents according to the perspective view of the scalpel of one or more embodiments and sheath.

Fig. 3 A-3E represents the syringe plunger rod according to one or more embodiments of the present invention.

Fig. 4 A-4F represents the syringe plunger rod according to one or more embodiments of the present invention.

Fig. 5 A-5F represents the syringe plunger rod according to one or more embodiments of the present invention.

Fig. 6 A-6F represents the syringe plunger rod according to one or more embodiments of the present invention.

Fig. 7 A-7F represents the syringe plunger rod according to one or more embodiments of the present invention.

Fig. 8 A-8F represents the syringe plunger rod according to one or more embodiments of the present invention.

Fig. 9 A-9F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 10 A-10F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 11 A-11F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 12 A-12F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 13 A-13F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 14 A-14F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 15 A-15F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 16 A-16F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 17 A-17F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 18 A-18F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 19 represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 20 represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 21 represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 22 A represents the syringe plunger rod according to one or more embodiments of the present invention.

The cross-sectional view of the syringe plunger rod of Figure 22 B presentation graphs 22A.

Figure 23 A-23F represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 24 represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 25 represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 26 A represents according to syringe plunger rod in one or more embodiments of the present invention.

The cross-sectional view of the syringe plunger rod in Figure 26 B presentation graphs 26A.

Figure 27 represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 28 represents the syringe plunger rod according to one or more embodiments of the present invention.

Figure 29 represents the syringe plunger rod according to one or more embodiments of the present invention.

Describe in detail

Describing before several exemplary embodiments of the present invention, be interpreted as the invention is not restricted to the detailed structure or the processing step that in the following description book, propose.The present invention can have other embodiment and can put into practice in many ways or implement.

Term used herein " medical device ", by all equipment and the parts that use together with miscellaneous part at equipment that comprise for all medical treatment and/or laboratory object, is got rid of waste collection container, for example sharp instrument collection container.Medical device comprises injector assembly, and it comprises syringe sleeve, plunger rod, conduit, needle hub and needle housings, safety guard, scalpel, operation handle, sharp instrument container, humor collecting equipment, tubing, joint, diverter, drainage tube, seal wire, support, culture dish, culture bottle, centrifuge tube, blood collecting equipment etc.As specified, " medical device " used herein gets rid of for example waste collection container of sharp instrument collection container.

Term used herein " biocompatible " should refer to health or biotic environment nontoxic, or is exposed to any material that does not produce less desirable biological respinse during human body.Biocompatible compositions also can be compatible with medical analysis type application (as laboratory research) with culture dish, makes material can not disturb the organic biological function for studying.(for example depend on use pattern, short-term is used or life-time service), if any catabolite of compositions and compositions does not have toxicity and biotic environment is not brought to significant adverse effect yet receptor or biotic environment, said composition is biocompatible.If any catabolite of medical device and medical device does not have toxicity and biotic environment is not brought to significant adverse effect receptor or biotic environment, this medical device is biocompatible.In detailed embodiment, biocompatible material meets the requirement of American Pharmacopeia and/or ISO10993.

In addition, term used herein " sterilizing is stable " should refer to that medical device or parts withstand sterilizing and functional characteristic and engineering properties do not have the significantly ability of loss.Sterilizing is included in the radiation that is exposed to for example gamma-rays and/or X-ray during sterilization process.Can withstand radiation sterilization and functional characteristic does not have medical device or its parts of significantly loss to can be described as " stable radiation ".The example of sterilization process can comprise makes medical device be exposed to the high-energy photon sending from the isotopic source of for example Co 60, and this isotopic source spreads all over medical device and produces ionizing or electronics destruction (electron disruption).Sterilizing also can comprise ethylene oxide sterilizing, electron beam sterilization, high pressure steam sterilization (steam sterilization), plasma sterilization, dry heat sterilization, chemosterilization and the sterilizing of X-beam.

At least a portion that term used herein " stream contact medical device " is medical device is wherein with for example medicine, medical solutions, contact or interactional medical device containing solution, rinse solution, body fluid, the human tissue of medicine or fluid and/or the solid that is intended to separate with antipollution any material.As used in this article, mention " being formed by the stable recycled resin compositions of sterilizing " medical device and refer to that this equipment is made up of the resin that obtaining from recycled resin, for example molding.Therefore, " being formed " medical device by the stable recycled resin compositions of sterilizing does not comprise and being used and subsequently by medical device clean or that via radiation or in autoclave, a part or whole equipment sterilizing are processed again.This often the reusing of medical device is called " processing " again, and process and do not comprise in order to the molding by resin combination forming device or other production technologies again due to this, in the scope of the equipment that the medical device of therefore processing again does not form in the recycled resin compositions stable by sterilizing.

A first aspect of the present invention relates to the compositions for molding medical device, and it comprises the recycled resin from retrospective source.A second aspect of the present invention relates to the medical device being formed by recycled resin compositions.A third aspect of the present invention relates to the method that forms medical device.

The medical device that comprises described syringe plunger rod can be by comprising new material, and the compositions of one or more in the recycled resin that sterilizing is stable and bio-based compositions is made.Described compositions can comprise and (for example has mixed source, with the plastics of the same type of the mixture of new material and recycled materials) one-component, or from same source (as, be the plastics of two types of new material) various ingredients.

The recycled resin compositions of one or more embodiments of first aspect can comprise industrial rear recycled resin.Industrial rear recycled resin can recycled resin compositions approximately 0.1 % by weight to the amount within the scope of approximately 100 % by weight be present in described recycled resin compositions.In one or more embodiments, described recycled resin compositions comprises the industrial rear recycled resin of approximately 50 % by weight to the amount within the scope of approximately 99 % by weight.In one or more concrete embodiments, described recycled resin compositions can comprise the industrial rear recycled resin of approximately 20 % by weight to the amount within the scope of approximately 80 % by weight.At one, more specifically in embodiment, the lower limit of the amount of industrial rear recycled resin can comprise 25 % by weight, 30 % by weight, 35 % by weight, 40 % by weight, 45 % by weight and 50 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The upper limit of the amount of industrial rear recycled resin can comprise 75 % by weight, 70 % by weight, 65 % by weight, 60 % by weight, 55 % by weight and 50 % by weight of described recycled resin compositions and all scopes and subrange betwixt.

The recycled resin compositions of one or more embodiments of first aspect can comprise the rear recycled resin of consumption.Described resin can any suitable form provide, for example, provide with forms such as thin slice, fragment, grains.In a variant, described recycled resin compositions can comprise the rear recycled resin of consumption and industrial rear recycled resin.Approximately 0.1 % by weight that after consumption, recycled resin can recycled resin compositions to the amount within the scope of approximately 100 % by weight is present in described recycled resin compositions.In one or more embodiments, described recycled resin compositions comprises that approximately 50 % by weight are to recycled resin after the consumption of the amount within the scope of approximately 99 % by weight.In one or more concrete embodiments, described recycled resin compositions can comprise that approximately 20 % by weight are to recycled resin after the consumption of the amount within the scope of approximately 80 % by weight.At one, more specifically in embodiment, after consumption, the lower limit of the amount of recycled resin can comprise 25 % by weight, 30 % by weight, 35 % by weight, 40 % by weight, 45 % by weight and 50 % by weight of described recycled resin compositions and all scopes and subrange betwixt.After consumption, the upper limit of the amount of recycled resin can comprise 75 % by weight, 70 % by weight, 65 % by weight, 60 % by weight, 55 % by weight and 50 % by weight of described recycled resin compositions and all scopes and subrange betwixt.

After suitable industrial rear recycled resin and consumption, the example of recycled resin comprises polypropylene, Merlon, nylon, polyethylene terephthalate, polyester, polyethylene, polystyrene, polylactic acid, polyhydroxyalkanoatefrom, comprises polyethylene and polyacrylic biologically-derived Polyolefin and other resins and combination thereof that can recirculation known in the art.Described recycled resin may (be consumed rear) and be reclaimed or move from solid waste circulation in addition during production process (before consumption) or after consumer is used.

In one or more embodiments, described recycled resin compositions also can comprise one or more in optional additive.The group of the freely following reagent composition of these optional additives choosing: antioxidant, slip agent, antistatic additive, anti-impact modifier, plasticiser, surfactant, coloring agent, plumper, x-ray fluorescence agent, radiation are covered filler, surface modifier, comprised the processing aid of melt stability agent, the nucleator that comprises clarifier, fire retardant, inorganic filler, organic filler and other polymer and reinforcing agent except fine-powdered Talcum.

In one or more embodiments, described recycled resin compositions comprises antioxidant ingredients.Described antioxidant ingredients can comprise the compound via chain termination reaction inhibited oxidation.In one or more embodiments, described antioxidant ingredients can be present in described recycled resin compositions up to the amount of recycled resin compositions approximately 10 % by weight.In one or more concrete embodiments, described recycled resin compositions can comprise up to the amount of described recycled resin compositions approximately 5 % by weight or more specifically up to the antioxidant ingredients of the amount of described recycled resin compositions approximately 1 % by weight.In one or more concrete embodiments, approximately 1 % by weight that described antioxidant ingredients can described recycled resin compositions to the amount within the scope of approximately 5 % by weight exists.In a more concrete embodiment, approximately 0.1 % by weight that described antioxidant ingredients can described recycled resin compositions to the amount within the scope of approximately 1 % by weight exists.The upper limit of the amount of described antioxidant ingredients can comprise 0.9%, 0.8%, 0.7%, 0.6% and 0.5% and all scopes and subrange betwixt.

In one or more embodiments, described antioxidant ingredients is to exist during being enough to be suppressed at sterilizing and in the amount of the shelf life of product and/or the oxidation reaction of operational phase.

The non-removing property example of suitable antioxidant component comprises hindered phenol, hindered amine, phosphite and/or its combination.Hindered phenol comprises serving as hydrogen donor and reacting with peroxy radical and forms hydroperoxides and prevent the compound that hydrogen is separated out from polymer backbone.Suitable hindered phenol comprises Yoshinox BHT.Other suitable hindered phenols can be at trade mark 1076, 1010, 3114 Hes under E201, be Ludwigshafen from now, the Ciba of a part of the BASF Corporation of Germany, Inc. obtains.Other examples of hindered phenol comprise and derive from Mayzo Inc. or Norcross, Georgia, U.S.A.'s 1010 Hes 1076TF.Suitable hindered phenol also can be at trade mark 330 Hes 376 times from Baton Rouge, Louisiana, and the Albemarle Corporation of U.S.A obtains.

Hindered amine comprises the compound that contains the amine functional group being surrounded by spatial environments.They are extremely effectively stabilizing agents of the photo-induced degraded of opposing most polymers.The example of suitable hindered amine comprises two (1,2,2,6,6-pentamethyl-4-piperidyl)-2-normal-butyl-2-(3,5-, bis--tertiary butyl-4-hydroxy benzyl) malonates; Two (2,2,6,6-tetramethyl-4-piperidyl) sebacate, two (1,2,3,6,6-pentamethyl-4-piperidyl) sebacate and two (1,2,2,6,6-pentamethyl-4-piperidyl) sebacate.These hindered amines are conventionally called Tinuvin144, Tinuvin770, Tinuvin292 and Tinuvin765 and are now Ludwigshafen certainly, and the Ciba-Geigy Corporation of a part of the BASF Corporation of Germany obtains.Other examples of suitable hindered amine can be from Bergamo under trade name Uvasorb HA-88, the 3V Sigma SpA of Italy obtain and under trade name Chimassorb944 and Chimassorb994 from Ludwigshafen, the BASF Corporation of Germany obtains.

In concrete embodiment, described recycled resin compositions comprises slip agent component.Described slip agent component can comprise and reduces the skin-friction coefficient of polymer and in order to strengthen processing or the compound of end use application.Described slip agent component can recycled resin compositions approximately 0.001 % by weight to the amount in approximately 5 % by weight scopes and all scopes and subrange be betwixt present in described recycled resin compositions.In one or more concrete embodiments, approximately 1 % by weight that described slip agent component can described recycled resin compositions to the amount within the scope of approximately 2 % by weight exists.The upper limit of the amount of described slip agent component can comprise 4.5 % by weight, 4.0 % by weight, 3.5 % by weight, 3.0 % by weight and 2.5 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit of the amount of described slip agent component can comprise 0.1 % by weight, 0.2 % by weight, 0.3 % by weight, 0.4 % by weight, 0.5 % by weight, 0.6 % by weight, 0.7 % by weight, 0.8 % by weight and 0.9 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The example of suitable slip agent component comprises oleamide, erucyl amide, oleyl palmitamide, stearyl erucyl amide, ethylidene-bis--oleamide, wax and combination thereof.

Described recycled resin compositions optionally comprises antistatic ingredient.Described antistatic ingredient can comprise the compound that prevents or reduce electrostatic accumulation.Described antistatic ingredient dissipates in order to allow body of material or its surface electrostatic, prevents from forming electrostatic charge and stops dust to be fixed.Described antistatic ingredient can be incorporated in material or can after molding, be administered to surface before molding, and by for electrostatic dissipation inherently or work by absorbing moisture from air.Described antistatic ingredient can be present in described recycled resin compositions in approximately 0.01 % by weight of recycled resin compositions to the amount in approximately 5 % by weight scopes and all scopes and subrange betwixt.In one or more concrete embodiments, approximately 0.1 % by weight that described antistatic ingredient can described recycled resin compositions to the amount in approximately 3.0 % by weight scopes and all scopes and subrange betwixt exists.The upper limit of the amount of described antistatic ingredient can comprise 4.5 % by weight, 4.0 % by weight, 3.5 % by weight, 3.0 % by weight and 2.5 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit of the amount of described antistatic ingredient can comprise 0.1 % by weight, 0.2 % by weight, 0.3 % by weight, 0.4 % by weight, 0.5 % by weight, 0.6 % by weight, 0.7 % by weight, 0.8 % by weight, 0.9 % by weight and 1.0 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The example of antistatic additive component is long-chain fat family amine and amide, phosphate ester, quaternary ammonium salt, Polyethylene Glycol, macrogol ester, ethoxylation long-chain fat family's amine and combination thereof.Other examples of suitable antistatic additive can be from Nagoya under trade name Pelestat230 and Pelestat300, and the Toyota Tsusho Corporation of Japan obtains, at trade name Atmer ^tM163 times is Yorkshire from now, England, and the Uniqema of a part of the Croda International Plc of Yorkshire of U.K. obtains, at trade name Entira ^tMunder MK400 from Wilmington, Delaware, the E.I DuPontde Nemours and Company of U.S.A. obtains and in trade name aP375 and 775 times are from Amsterdam, and the Akzo Nobel N.V. of the Netherlands obtains.

Described recycled resin compositions optionally comprises anti-impact modifier component.Described anti-impact modifier component can comprise the compound of the impact resistance of goods in order to have improved or equipment.Described anti-impact modifier component can be present in described recycled resin compositions in approximately 0.1 % by weight of recycled resin compositions to the amount within the scope of approximately 30 % by weight.In one or more concrete embodiments, approximately 0.5 % by weight that described anti-impact modifier component can described recycled resin compositions to the amount in approximately 5 % by weight scopes and all scopes and subrange betwixt exists.The upper limit of the amount of described anti-impact modifier component can comprise 4.5 % by weight, 4.0 % by weight, 3.5 % by weight, 3.0 % by weight, 2.5 % by weight and 2.0 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit of the amount of described anti-impact modifier component can comprise 0.75 % by weight, 1.0 % by weight, 1.25 % by weight, 1.5 % by weight, 1.75 % by weight and 2.0 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The example of suitable anti-impact modifier component comprises ethylene-butene copolymer, ethylene-octene copolymer, ethylene-propylene copolymer, methacrylate butadiene-styrene core-shell impact modifiers and combination thereof.The example of suitable anti-impact modifier is in trade name under EAC3427 from Wilmington, Delaware, the E.I DuPont de Nemours and Company of U.S.A. obtains, at trade name Engage ^tMand Versify ^tMunder from Midland, Michigan, the Dow Chemical Company of U.S.A. obtains and at trade name Clearstrength ^tMunder from Philadelphia, Pennsylvania, the Arkema Inc. of U.S.A. obtains.

In the situation that there is anti-impact modifier component, the amount that anti-impact modifier component can be enough to the impact demand of the medical article that meets manufacturing exists.

Described recycled resin compositions optionally comprises plumper component.Described plumper component can comprise and prevent that polymer from fading or premature aging, and the medical article of manufacturing during production, processing, sterilizing, storage life or operating period away from the compound of acid impurities.For example, described compound can in and the halide anion that may form due to the impact of the heat between processing period and shearing force seen in resin combination.Described plumper component is removed these hydracids to prevent depolymerization or corrosion.Described plumper component can be present in described recycled resin compositions in approximately 0.01 % by weight of recycled resin compositions to the amount within the scope of approximately 1 % by weight.In one or more concrete embodiments, approximately 0.1 % by weight that described plumper component can described recycled resin compositions to the amount in approximately 0.5 % by weight scope and all scopes and subrange betwixt exists.The upper limit of the amount of described plumper component can comprise 0.6 % by weight, 0.7 % by weight, 0.8 % by weight and 0.9 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit of the amount of described plumper component can comprise 0.01 % by weight, 0.02 % by weight, 0.03 % by weight, 0.04 % by weight, 0.05 % by weight, 0.06 % by weight, 0.07 % by weight, 0.08 % by weight and 0.09 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The example of suitable plumper component comprises long-chain carboxylic acid's slaine, as the stearate of calcium, zinc or sodium, lactate, natural or synthetic silicate as brucite, metal-oxide (for example magnesium oxide, calcium oxide, zinc oxide), metal carbonate (for example calcium carbonate) or metal hydroxides (referring to, for example A Holzner, K Chmil in H.Zweifel, Plastic Additives Handbook, the 5th edition, Hanser Publisher, Munich2001, chapter 4 plumper).The suitable example of plumper comprises calcium stearate, dihydro talcite, calcium lactate, citric acid list potassium and combination thereof.

In the situation that there is plumper component, plumper component can be enough to be suppressed at polymer and the variable color that caused by acid impurities during production, processing, storage, storage life or operating period by the medical article of its manufacture or the amount of degraded are present in described recycled resin compositions.

Another optional components of described recycled resin compositions is that filler component is covered in radiation.Described radiation is covered filler component and can be comprised and make medical device visible compound under fluoroscopy or X-radial imaging of being formed by resin combination.Described radiation is covered approximately 10 % by weight to the amount in approximately 48 % by weight scopes and all scopes and subrange betwixt that filler component can recycled resin compositions and is present in described recycled resin compositions.In one or more concrete embodiments, described radiation is covered approximately 22 % by weight to the amount in approximately 25 % by weight scopes and all scopes and subrange betwixt that filler component can described recycled resin compositions and is existed.The upper limit that the amount of filler component is covered in described radiation can comprise 26 % by weight, 28 % by weight, 30 % by weight, 32 % by weight, 34 % by weight, 36 % by weight, 38 % by weight, 40 % by weight, 42 % by weight, 44 % by weight and 46 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit that the amount of filler component is covered in described radiation can comprise 11 % by weight, 12 % by weight, 13 % by weight, 14 % by weight, 15 % by weight, 16 % by weight, 17 % by weight, 18 % by weight, 19 % by weight and 20 % by weight of described recycled resin compositions and all scopes and subrange betwixt.Also can use the radiation of higher percent to cover filler component.For example, the amount that filler component is covered in described radiation can be greater than approximately 50 % by weight of described recycled resin compositions.The example that filler component is covered in suitable radiation comprises barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten and combination thereof.

Described radiation is covered filler component and can be used the amount of the observability of X-ray and other radiology imaging techniques to exist by sufficient to guarantee medical device.

Described recycled resin compositions further optionally comprises surface modifier component.Described surface modifier component can comprise that the surface of the assembly that customizes manufacturing is to meet or to strengthen compound or the material of cohesiveness, lubricity and/or physical characteristic.Described surface modifier component can recycled resin compositions approximately 0.1 % by weight to the amount within the scope of approximately 10 % by weight % be present in described recycled resin compositions.In one or more concrete embodiments, approximately 0.5 % by weight that described surface modifier component can described recycled resin compositions is to approximately 5 % by weight scopes, more preferably the amount in all scopes and subrange between 0.2 % by weight to 1 % by weight and betwixt exists.The upper limit of the amount of described surface modifier component can comprise 1.5%, 2.0%, 3.0%, 3.5%, 4.0% and 4.5% and all scopes and subrange betwixt.The lower limit of the amount of described surface modifier component can comprise 0.3 % by weight, 0.35 % by weight, 0.4 % by weight and 0.45 % by weight of described recycled resin compositions and all scopes and subrange betwixt.In one or more embodiments, also can use the surface modifier of higher percentage ratio.The example of appropriate surfaces modifier components comprises kieselguhr, Talcum, calcium carbonate, organosilan, titanate, maleinization polyolefin, powder PTFE and combination thereof.

The amount that described surface modifier can be enough to the desirable surface nature in surface of the medical device of giving manufacturing is present in described recycled resin compositions.

In one or more embodiments, described recycled resin compositions comprises coloring agent component.Described coloring agent component can recycled resin compositions approximately 0.01 % by weight to the amount within the scope of approximately 5 % by weight be present in described recycled resin compositions.In one or more concrete embodiments, approximately 0.5 % by weight that described coloring agent component can described recycled resin compositions to the amount in the scope of approximately 3 % by weight and all scopes and subrange betwixt exists.The upper limit of the amount of coloring agent component can comprise 3.25 % by weight, 3.5 % by weight, 3.75 % by weight, 4.0 % by weight, 4.25 % by weight, 4.5 % by weight and 4.75 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit of the amount of described coloring agent component can comprise 0.1 % by weight, 0.15 % by weight, 0.2 % by weight, 0.25 % by weight, 0.3 % by weight, 0.35 % by weight, 0.4 % by weight and 0.45 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The example of suitable coloring agent component includes organic dye, inorganic pigment, white carbon black, channel black, titanium dioxide and combination thereof.Organic dyestuff can comprise phthalocyanine blue and phthalocyanine green and FD & C coloring agent.Exemplary inorganic pigment comprises ultramarine and ferrum oxide.

Another optional component of described recycled resin compositions comprises processing aid component.Described processing aid component can comprise improve high molecular polymer machinability, reduce circulation time and help improve the compound of the quality of manufactured goods.Described processing aid component can recycled resin compositions approximately 0.05 % by weight to the amount in the scope of approximately 5 % by weight and all scopes and subrange be betwixt present in described recycled resin compositions.In one or more concrete embodiments, approximately 0.1 weight that described processing aid component can described recycled resin compositions to the amount in the scope of approximately 3 % by weight and all scopes and subrange betwixt exists.The upper limit of the amount of coloring agent component can comprise 3.25 % by weight, 3.5 % by weight, 3.75 % by weight, 4.0 % by weight, 4.25 % by weight, 4.5 % by weight and 4.75 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit of the amount of described coloring agent component can comprise 0.06 % by weight, 0.07 % by weight, 0.08 weight and 0.09 % by weight of described recycled resin compositions and all scopes and subrange betwixt.Also can use the processing aid of higher percentage ratio.The example of suitable processing aid component comprises fatty acid ester, fatty acid amine, wax, oxidic polyethylene, colloid fumed silica particle and combination thereof.Colloid fumed silica particle can be from Old Chatham under trade name Nan-O-Sil ASD, New York, and the Energy Strategy Associates of USA., Inc. and other suppliers obtain.Glyceryl monostearate and bis-stearamides are suitable fatty acid ester and fatty acid amides.

Described recycled resin compositions optionally comprises nucleator and/or clarifier component.Nucleator can comprise that enhancing resin property character is as hardness and stable on heating compound.Also can add clarifier to be formed more transparent its aesthstic attractive force that strengthens of product by making.In one or more embodiments, described nucleation and/or clarifier component exist with approximately 0.005 % by weight to the amount of approximately 3 % by weight of described recycled resin compositions.Can use nucleation and/or the clarifier of higher percent, but it does not provide the advantage that can discover conventionally.In one or more concrete embodiments, approximately 0.05 weight that described clarifier component can described recycled resin compositions to the amount in the scope of approximately 0.5 % by weight and all scopes and subrange betwixt exists.The upper limit of the amount of described clarifier component can comprise 1.0 % by weight, 1.5 % by weight, 2.0 % by weight and 2.5 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit of the amount of described clarifier component can comprise 0.01 % by weight, 0.015 % by weight, 0.02 % by weight, 0.025 % by weight, 0.03 % by weight, 0.035 % by weight, 0.04 % by weight and 0.045 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The example of clarifier component comprises as U.S. Patent number 4,016, the dibenzylidene sorbitol described in 118, and this patent is incorporated herein by reference; As U.S. Patent number 4,371, the dibenzylidene sorbitol of the replacement described in 645, this patent is incorporated herein by reference; With as at U.S. Patent number 4,994, the dibenzylidene sorbitol sulfide derivative described in 552, this patent is incorporated herein by reference.

In the situation that there is clarifier, described clarifier can be enough to make the size of crystal in gained resin combination to be less than visible light wavelength to exist with the amount that prevents the light scattering that causes opacity.

Described recycled resin compositions optionally comprises enhancer component.The amount of described enhancer component within the scope of can approximately 1 % by weight-35 % by weight of recycled resin compositions is present in described recycled resin compositions.In one or more concrete embodiments, approximately 5 % by weight that described enhancer component can described recycled resin compositions to the amount in approximately 30 % by weight scopes and all scopes and subrange betwixt exists.The upper limit of the amount of described enhancer component can comprise 30.5 % by weight, 31 % by weight, 31.5 % by weight, 32 % by weight, 32.5 % by weight, 33 % by weight, 33.5 % by weight, 34 % by weight and 34.5 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The lower limit of the amount of described enhancer component can comprise 1.5 % by weight, 2 % by weight, 2.5 % by weight, 3 % by weight, 3.5 % by weight, 4 % by weight and 4.5 % by weight of described recycled resin compositions and all scopes and subrange betwixt.The example of suitable enhancer component comprises glass fibre, slag ash, natural fiber and mineral, carbon fiber, ceramic fibre and combination thereof.The example of natural fiber comprises flax fiber and bastose and filler, and they are bio-based materials.Described enhancer component can nanofiber and/or form of nanoparticles be present in described recycled resin compositions.

Optionally comprise melt stability agent component according to the recycled resin compositions of one or more embodiments.Described melt stability agent component can comprise the compound for regulating the viscosity of described recycled resin compositions during melting process.

Described recycled resin compositions is also optionally incorporated to non-recycled resin component.The example of non-recycled resin component comprises new resin Composition, bio-based resin component and combination thereof.New resin Composition is the resin combination that does not comprise the recycled resin of significant quantity.In one or more embodiments, new resin Composition is not containing recycled resin.New resin Composition also can comprise " based on the polymer of Fossil fuel (fossil fuel) " or " based on the polymer of oil ", and they can exchange and use and include, without being limited to the polymer being formed by the non-renewable resources of for example fossil fuel source.Described polymer comprises Merlon and not derives from polypropylene, the polyethylene of sugar or other Renewable resources.

Term " bio-based " can exchange and use with term " biological formation " and " biologically-derived ".Described bio-based component comprises entirety or signal portion by living resources or reproducible domestic Agricultural Materials (comprising plant, animal and ocean material) or forestry material obtains, manufactures or synthetic component.For example, described bio-based component comprise wherein carbon via bioprocess technology as the microorganism polymer obtaining from reproducible resource that ferments.Described bio-based component also can comprise the polymer based on cellulosic material with different brackets.Described bio-based component also can comprise as measured the substantially polymer containing the material obtaining from Fossil fuel or non-renewable resources by ASTM D6866-08.

Bio-based component used herein can comprise the polymer obtaining from the biogenic of for example plant, and comprises the polymer being derived by polysaccharide, for example starch or carbohydrate-derived polymer, and the derivative polymer of sugar.The starch that is used to form the biological polymer forming can obtain from corn, Rhizoma Solani tuber osi, Semen Tritici aestivi, Maninot esculenta crantz., large rice and other plant.The example of the compositions that contains the polymer that the biology that obtains from starch forms is from Cereplast Inc., Hawthorne, and California, U.S.A. is at trade mark and trade name Cereplast Hybrid or Biopropylene50 ^tMlower acquisition.The sugar that is used to form the biological polymer forming of this class can obtain from Caulis Sacchari sinensis.This class derives from sugared polymer and comprises polyethylene (it can be produced also subsequently in order to manufacture ethylene by the ethanol that derives from Caulis Sacchari sinensis), and from Novamount S.P.A., Novara, Italy is at trade mark the polymer of lower acquisition.Other examples of the biological polymer forming are described in U.S. Patent number 7,393,590, in U.S. Patent Application Publication case number 2008/0113887 and 2008/0153940, the open case WO07/099427 of PCT application and WO07/063361 and european patent number 1725614, it is all incorporated herein separately by reference.The instantiation of the biological polymer forming comprises " poly-(lactic acid) " or " PLA ", and it can comprise the synthetic polymer being generated by sucrose or corn starch.PLA is from NatureWorks LLC, Minnetonka, and Minnesota, U.S.A. is at trade name Ingeo ^tMlower acquisition.Use the embodiment of PLA also can comprise ethylene copolymer, ethylene copolymer is from E.I.du Pont de Nemours and Company, Wilmington, and Delaware, U.S.A. is at trade mark lower acquisition.

Bio-based component comprises the polymer that also can be generated by microorganism.Microorganism produces by growth on the raw material comprising glycogen material the material that comprises polymer.The generation of these polymer also can relate to the bacterial fermentation of sugar or lipid.Described bio-based component can be further processed or be synthesized by natural product.This class generates and/or the example of synthetic bio-based polymers comprises polyhydroxyalkanoatefrom.Term " polyhydroxyalkanoatefrom " or " PHA " comprise the straight chain polyester that the bacterial fermentation by sugar or lipid generates in essence.The example of PHA comprises poly-(butyric ester) and poly-(hydroxyl valerate) or " PHBV ".PHA can demonstrate for example elastic character.PHA is from Metabolix, Inc., and Cambridge, Massachusetts, U.S.A. is at trade mark lower acquisition.

As defined herein, be biocompatible according to the recycled resin compositions of one or more embodiments.In one or more embodiments, described recycled resin compositions can withstand and be exposed to gamma-rays, electron beam, X-ray, ethylene oxide gas, xeothermic, peroxide gaseous plasma, peracetic acid, steam high-voltage sterilizing device and other sterilizing installations.In one or more embodiments, described recycled resin compositions to stable radiation and can stand to be exposed to about 5kGys to about 75kGys or more specifically about 25kGys to the gamma-rays within the scope of about 50kGys.In one or more embodiments, described recycled resin compositions can withstand and be exposed to about 30kGys to the extremely electron beam within the scope of about 70kGys of about 40kGys in about 80kGys or more specifically.

There is about 3dg/min to the melt flow rate (MFR) within the scope of about 80dg/min according to the recycled resin compositions of one or more embodiments.In one or more concrete embodiments, described recycled resin compositions has about 8dg/min to the melt flow rate (MFR) within the scope of about 40dg/min.In embodiment more specifically, described recycled resin compositions has about 11dg/min to the melt flow rate (MFR) within the scope of about 30dg/min.Term used herein " melt flow rate (MFR) " refers to the mobile easness of the melt of recycled resin compositions as herein described.

Recycled resin compositions as herein described can have as according to the flexural modulus in the measured about 70kpsi-350kpsi scope of ASTM D790 method of testing and all scopes and subrange betwixt.In a detailed embodiment, described recycled resin polymer has the flexural modulus of about 75kpsi to about 300kpsi.In one or more concrete embodiments, described recycled resin compositions has about 100kpsi to the flexural modulus within the scope of about 300kpsi.In embodiment more specifically, described recycled resin compositions display goes out about 130kpsi to the flexural modulus within the scope of about 270kpsi.

The feature of described recycled resin compositions can be to have as according to the measured about 0.1ft-lb/in. of ASTM D256 method of testing to the gap Izod impact strength (notched izod impact strength) in about 4.0ft-lb/in. scope and all scopes and subrange.In one or more embodiments, described recycled resin compositions can have the gap Izod impact strength of about 0.2ft-lb/in. within the scope of to about 3.0ft-lb/in. or about 0.2ft-lb/in. to about 1.5ft-lb/in..In one or more concrete embodiments, described recycled resin compositions can have about 0.3ft-lb/in. to the gap Izod impact strength within the scope of about 1.0ft-lb/in..Term used herein " gap Izod impact strength " relates to the ASTM standard method of measuring impact strength.

One or more embodiments of recycled resin compositions as herein described can characterize by the heat distortion temperature having within the scope of approximately 60 DEG C to approximately 260 DEG C.Term used herein " heat distortion temperature " comprises at high temperature measuring to polymer resistance to deformation under fixed load.This heat distortion temperature also referred to as " load deformation temperature " (DTUL), deformation temperature or " hot torsion temperature " (HDT).0.46MPa (66psi) and 1.8MPa (264psi) for two kinds of common load measuring heat distortion temperature, although frequently run into the test of carrying out under the higher load of for example 5.0MPa (725psi) or 8.0MPa (1160psi).Conventional ASTM test is ASTM D648, and similarly ISO test is ISO75.Use the test of 1.8MPa load to carry out under ISO75 method A, and use the test of 0.46MPa load to carry out under ISO75 method B.In one or more concrete embodiments, described recycled resin compositions can have the heat distortion temperature within the scope of approximately 68 DEG C to approximately 140 DEG C, or heat distortion temperature within the scope of approximately 68 DEG C to approximately 130 DEG C.In embodiment more specifically, described recycled resin compositions can have the heat distortion temperature within the scope of approximately 70 DEG C to approximately 95 DEG C.In the embodiment of industrial rear recycled resin component that comprises Merlon in one or more uses, described recycled resin compositions has the heat distortion temperature of approximately 140 DEG C and under the load of 1.8MPa, has the heat distortion temperature of 130 DEG C under the load of 0.46MPa.The industrial rear recycled resin component that comprises nylon in one or more uses and comprising in the embodiment of enhancer component of glass fibre, described recycled resin compositions has the heat distortion temperature of approximately 220 DEG C and under the load of 1.8MPa, has the heat distortion temperature of 200 DEG C under the load of 0.46MPa.The industrial rear recycled resin component that comprises PET in use and comprising in the embodiment of enhancer component of glass fibre, described recycled resin compositions has the heat distortion temperature of approximately 250 DEG C and under the load of 1.8MPa, has the heat distortion temperature of 230 DEG C under the load of 0.46MPa.

The preparation of recycled resin compositions of the present invention can realize by any suitable blend known in the art or mixing apparatus.Blend step is among at least minimally is dispersed in each other by component.Component can be blended together in single-step method or multistep processes.In single-step method, all components is blended together simultaneously.In multistep processes, two or more components are blended together to form the first mixture and subsequently by one or more and this first mixture blend in remaining ingredient.If still remaining one or more components, can be by the blend in blend step subsequently of these components.In one or more embodiments, all components is blend in one step.

In one or more embodiments for the election, recirculation polypropene composition can be by the single component of dry type blend and directly melting mixing or the incompatible preparation of premix in independent extruder in the extruder in order to manufacture making articles subsequently.The dry type blend of described compositions also can be in the situation that not carrying out pre-fusion mixing direct injection molding.

Recycled resin compositions disclosed herein in order to molding, extrude or form medical device in other mode.In one or more embodiments, described medical device is disposable.The medical device that for example, can be formed by recycled resin compositions as herein described can be used in injection, infusion, blood collecting, operation application and other application known in the art.The instantiation of the medical device that can be formed by recycled resin compositions as herein described comprises syringe (comprising syringe sleeve, needle hub part, plunger rod, needle housings etc.), safety injector, conduit, blood collection device, scalpel or dissecting knife and other such equipment and assembly.In one or more embodiments for the election, described medical device can be completely or partially by recycled resin compositions molding.For example, the inner surface of syringe sleeve can be formed by the resin combination of recirculation not, and the outer surface of this syringe sleeve or the finger flange of this syringe sleeve are made up of recycled resin compositions.In one or more embodiments for the election, scalpel handle or needle housings are formed by recycled resin compositions.

In one or more embodiments, the medical device being formed by recycled resin compositions as herein described is characterised in that non-stream contact assembly or medical device.Like this, described medical device and assembly be not with medicine for example, medical solutions, containing solution, rinse solution, body fluid, the human tissue of medicine or be intended to separate fluid and/or solid-phase mutual effect and/or the contact with antipollution any material.The example of this class equipment comprises handle, the conduit wing, catheter flow control cock of syringe plunger rod, needle housings, the safety guard of injection equipment and the finger flange of syringe sleeve, the periphery IV conduit of three-member type syringe etc.The medical device being formed by recycled resin compositions is characterised in that with assembly stream contacts medical device.This class medical device or medical device assembly can comprise the plunger rod of syringe sleeve, needle hub, blade holder, valve chamber, syringe stoppers, two-piece type syringe.

The limiting examples of medical device is shown in Fig. 1 and Fig. 2.Fig. 1 shows injector assembly 100, it comprise have the inner surface that limits chamber syringe sleeve 110, be placed in plunger rod 120 in described chamber, comprise the needle hub 130 of the needle cannula 140 for being connected to syringe sleeve.Fig. 1 also shows and is connected to needle hub 130 to protect and to cover the optional needle housings 150 of needle cannula 140.Plunger rod 120 has the main body 121 of elongation, and it extends between near-end 122 and far-end 123, and described near-end 122 and described far-end 123 limit the length of the main body 121 of extending.Plunger rod have the main body 121 that is positioned at elongation near-end 122 places finger pressure 124 and be positioned at the stopper eyelid retractor 126 at far-end 123 places of the main body 121 of elongation.Stopper eyelid retractor 126 can be the structure for any appropriate of support plug 125.As shown in Figure 1, plunger rod 120 can comprise independently stopper 125, and it is connected to an end of plunger rod 120, for forming fluid-tight with the inner surface of syringe sleeve.In one or more optional embodiments, plunger rod 120 can comprise the effect of playing stopper hermetic unit (not shown) and can with integrally molding and therefore being formed by the material identical with plunger rod 120 of plunger rod 120.The syringe sleeve 110 showing in Fig. 1 is also included in Rule (luer) joint 112 of one end of syringe sleeve 110 and the finger flange 114 in the end opposite of syringe sleeve 110.

In a variant, described syringe sleeve can be formed by recycled resin compositions disclosed herein completely.Alternatively, female Luer 112 and/or finger flange 114 can be formed by recycled resin compositions disclosed herein, and syringe sleeve 110 is by can comprising new resin Composition and/or bio-based resin component and not forming containing the known resin compositions of any recycled resin.In one or more optional structures, the inner surface of syringe sleeve 110 can be with comprising new resin Composition and/or bio-based resin component and not containing the known resin compositions coating of any recycled resin, and the remainder of syringe sleeve 110 is formed by one or more in recycled resin compositions as herein described.

In a variant, plunger rod 120 can be formed by recycled resin compositions as herein described.Sealing the margin (not shown) being incorporated in the embodiment of plunger rod 120, sealing edge (not shown) also can be formed by recycled resin compositions as herein described.In one or more embodiments, stopper 125 can be formed by elastomeric material or other known materials, and plunger rod forms and be connected to stopper 125 by described recycled resin compositions.

In one or more embodiments, needle hub 130 can be formed by recycled resin compositions as herein described, and needle cannula 140 is made up of material known in the art.In one or more optional structures, needle housings 150 also can be formed by recycled resin compositions disclosed herein.

Fig. 2 shows and comprises the handle 210 of elongation and for cutter (not shown) being connected to the dissecting knife 200 of handle of a knife 220 of handle of this elongation.Dissecting knife 200 also comprises and is detachably connected to the handle 210 of elongation and/or the handle of a knife 220 cutter guard shield 230 with protection cutter (not shown).In one or more embodiments, the handle 210 of elongation, handle of a knife 220 and/or cutter guard shield 230 can be formed by recycled resin compositions as herein described.

Fig. 3 A shows the multi-angle figure of embodiment of the present invention to 3E.With reference to figure 3A, the main body 121 of elongation is cylindrical, and running through it has multiple openings 160.Described multiple opening 160 is along the length interval of the main body 121 of extending.Described opening has reduced the weight of plunger rod and the amount for the material of constructional column stopper rod.Described opening 160 can be formed by the method for any appropriate, and it includes but not limited to, boring and the part as mould.The side view of the plunger rod in Fig. 3 B displayed map 3a.The top view of the plunger rod of Fig. 3 C displayed map 3A.Figure when Fig. 3 D and 3E show respectively from far-end and near-end observation.Although multiple openings 160 are depicted as circle, it can be any applicable shape that those skilled in the art can understand this opening.The example of various shape spreads all over accompanying drawing and shows.All these examples should not be served as the restriction of the scope of the invention.

With reference to figure 4A-4F, some embodiments of syringe thromboembolism bar have the main body 121 of the elongation that comprises at least one rib 165, and described rib 165 extends the length of the main body 121 of described elongation.At least one in described at least one rib 165 comprises multiple isolated openings 160.Fig. 4 A-4F shows another embodiment of syringe thromboembolism bar, and it has four ribs 165, and wherein two have multiple openings 160.Fig. 4 A-4E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Described four ribs 165 are set, and to make cross section (shown in Fig. 4 F) be plus sige shape.In numerous embodiments, all four ribs 165 have opening 160, or wherein three ribs 165 have opening 160, or only have a rib 165 to have opening 160.In detailed embodiment, at least one in rib 165 but be less than all ribs 165 and there is opening 160.

In some embodiments, as shown in Figure 4 A, the main body of elongation comprises at least two ribs, and described rib extends the length of the main body of described elongation, and the opening at described multiple intervals is positioned at along the length that is less than all ribs.With reference to figure 4A, the main body of elongation has four ribs that extend the length of described main body, but opening only exists along two in described four ribs.Therefore, opening is being less than on all ribs.Rib described herein is only example with the number of the rib with opening, should not be construed as limitation of the scope of the invention.

Fig. 5 A shows another embodiment of the syringe thromboembolism bar with four ribs.In described rib two are shown with the opening at multiple intervals, but should be understood to arbitrarily or whole ribs can have opening.Fig. 5 A-5E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Fig. 5 F shows the cross section of rib and shows plug (plug) shape structure.

Fig. 6 A shows another embodiment of the syringe thromboembolism bar with four ribs.In described rib two are shown with the opening at multiple intervals, but should be understood to arbitrarily or whole ribs can have opening.Fig. 6 A-6E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Fig. 6 F shows the cross section of rib and shows plug-shaped columnar structure.

In some embodiments, the main body of elongation comprises three ribs.For example this can be illustrated in Fig. 7 A to 7F.In Fig. 7 A to 7F, the opening at multiple intervals is on all ribs.But, should be understood to that opening can be positioned at arbitrarily or whole rib and can there is arbitrary shape.In detailed embodiment, multiple isolated openings are arranged in along two of three ribs.In concrete embodiment, multiple isolated openings are arranged on of three ribs.Fig. 7 A-7E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Fig. 7 F shows the cross-sectional view with the main body of the elongation of three ribs.

Fig. 8 A-8F shows another embodiment of the present invention, wherein along between the length of the main body 121 of extending, is separated with multiple supporting walls 168.In the embodiment shown, described three ribs run through multiple openings of each rib.Described opening is larger, makes the material of rib relatively less.Described supporting walls 168 can be distributed in any or whole openings, and provides extra support for plunger rod.Fig. 8 A-8E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Fig. 8 F shows the cross-sectional view of the main body of the elongation with three ribs and supporting walls.

Fig. 9 A shows another embodiment of the invention, and wherein plunger rod has four ribs of plus sige shape.In this embodiment, part rib has the difformity that comprises breach.Described breach can obviously not affect the use of plunger rod for reducing the amount of plunger rod structure material.Fig. 9 A-9E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Fig. 9 F shows the sectional view of the main body of the elongation with four ribs.

Figure 10 A shows another embodiment of the invention, and wherein plunger rod has three ribs.In this embodiment, some ribs have the difformity that comprises breach, and Figure 10 A-10E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Figure 10 F shows the sectional view of the main body of the elongation with three ribs.

Figure 11 A shows another embodiment of the invention, and wherein plunger rod has three ribs, and multiple opening is semilune shape.Figure 11 A-11E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Figure 11 F shows the sectional view of the main body of the elongation with three ribs.

Figure 12 A shows another embodiment of the invention, and wherein plunger rod has the rib of two V-arrangements.In order to strengthen this structure, comprise that multiple supporting walls at the length interval of multiple main bodys along extending are useful.Figure 12 A-12E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Figure 12 F shows the cross-sectional view of the main body of the elongation with two ribs and supporting walls.

Figure 13 A shows another embodiment of the invention, and wherein plunger rod has four ribs of plus sige shape, and two other is along the rib of the axle extending, and one is positioned at the upside of main cross rib, and another is positioned at the downside of main cross rib.Figure 13 A-13E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Figure 12 F illustrates four main ribs of plus sige shape and is shown the cross-sectional view of the main body of the elongation of two other rib of the main cross rib upside of the level of being positioned at and downside.

Figure 14 A shows another embodiment of the invention, and wherein plunger rod has wherein with the cylindrical, hollow shape of the elongation of hollow bulb and at the finger pressure of near-end.Finger pressure can have the opening aliging with the hollow form extending, and can be also the solid construction of the hollow bulb of the cylinder-shaped body of sealing elongation.The cylindrical, hollow shape of described elongation can be open-ended, one end sealing (near-end or far-end) or closed at both ends.Enclosed construction can be one-body molded, or can be an independent sheet that is connected to hollow circuit cylinder.The wall of the hollow main body of extending can have the thickness of any appropriate, and it provides enough intensity for bearing promotion thromboembolism bar by syringe sleeve.But thicker wall has more intensity also needs extra material to manufacture.Figure 14 A-14E shows respectively perspective view, side view, top view, the figure observing from the near-end of thromboembolism bar and the figure observing from thromboembolism bar far-end.Figure 14 F shows the cross-sectional view of the hollow main body of extending.

The hollow main body of extending and the shape of hollow bulb can change.In concrete embodiment, the shape of hollow bulb is similar to the shape of the main body of elongation.For example, the main body of elongation can be circle and hollow bulb and can be the circle of the shape of the main body of the described elongation of coupling.In various embodiments, the main body of elongation and hollow bulb are respectively square, rectangle or octagon.In addition, the shape of hollow bulb also can be different from the shape of the main body of extending.For example, the main body of foursquare elongation can have circular hollow bulb, and its length along the main body of this elongation is extended.

Figure 15 A shows another embodiment of the invention, and wherein plunger rod has the hollow shape similar to shape shown in Figure 14 A.In Figure 15 A-15F, described hollow plunger rod has along the combination of the axially extended rib of length of hollow main body.Rib is depicted as plus sige columnar structure.Described rib can extend the whole length of described main body or along partial-length.In the embodiment shown, rib extends to the point of the length of about 2/3 plunger rod from one end of the stopper of plunger rod.At this point, rib is tapered towards the inside of hollow plunger rod.Those skilled in the art can understand that this just shows a concrete embodiment, and the length that described rib extends along plunger rod can change.In addition the end of rib taper can be blunt or as shown in the figure.Taper can have desired shape arbitrarily and length.

Figure 16 A-16F shows the like configurations of the rib extending with three length along hollow main body.Figure 17 A-17F shows that the main body of the sleeve extending is foursquare like configurations.Figure 18 A-18F shows that the main body of the sleeve extending is the octagonal like configurations of extending, the shape of cross section that those skilled in the art can understand the hollow body of elongation can be the shape of any appropriate, include but not limited to triangle, pentagon, hexagon, heptagon, nonagon and decagon.

Figure 19-29 show numerous embodiments of the present invention.Plunger rod can be cylindrical or be made up of multiple ribs, and can have supporting walls.Embodiment is only exemplary, should not be used as limitation of the scope of the invention.Figure 22 A shows that the main body of extending has the hollow bulb of the main body that is closed in described elongation.It fully shows in the cross-sectional view of Figure 22 B.Here, hollow bulb is completely contained in the main body of elongation, still, is understandable that, hollow bulb can extend to the wherein one or both ends of the main body of elongation.

Figure 23 A shows a detailed embodiment of the present invention, wherein the length of the main body of three main rib extension elongations.With reference to figure 23A-23F, the opening at multiple intervals is along an extension of described three ribs.In addition, there are the multiple openings of multiple supporting walls in abutting connection with the length of the main body along extending.This has spatially saved material, and provides extra support structure with supporting walls.The top view (upward view) of the plunger rod in Figure 23 B displayed map 23A.The left view (right view) of the plunger rod in Figure 23 C displayed map 23A.Figure 23 D and 23E show respectively the figure looking down from finger pressure side and the figure looking down from stopper eyelid retractor side.Cross-sectional view in Figure 23 F shows the shape of supporting walls.

Other embodiment of the present invention relates to a syringe plunger rod, and it comprises the main body of the elongation of at least one opening with the main body that runs through elongation.As shown in Figure 5A, described at least one opening can make opening extend perpendicular to the axle extending along the length of main body.As shown in Figure 14 A, described at least one opening extends along the length of the main body of extending.In some embodiments, exist simultaneously along the combination of the opening extending with the axle perpendicular to extending.Described syringe plunger rod can be by comprising that one or more in new material, sterilizing stable recycled resin and bio-based compositions make.

In one or more embodiments, the medical device being formed by recycled resin compositions described herein does not change color after sterilizing, and this available yellowness index is measured.For example, as mentioned above, can there is by sterilizing and not color or apparent variation in medical device.

Described medical device can use the whole bag of tricks known in the art to form.For example, the method comprises injection moulding, blowing, extrudes and/or rotational molding.Additive method known in the art also can be used for forming medical device or parts.

The medical device being formed by described recycled resin compositions can comprise the plunger rod demonstrating by user and/or the acceptable functional characteristic of clinician.

In one or more embodiments, the plunger rod being formed by above-mentioned recycled resin compositions demonstrate with by acyclic resin combination or do not comprise the functional characteristic that plunger rod that the compositions of any recirculation composition forms is identical.

The 3rd aspect of the present invention relates to a kind of method that forms medical device and parts.In one or more embodiments, described method comprises the melt blended composition that recycled resin compositions described herein is provided.Described method comprises stablizes this melt blended composition, and said composition is solidified into previously selected shape, and this can comprise handle, needle housings and the needle hub of plunger rod, syringe sleeve, conduit, blood collection device, scalpel.In one or more embodiments, stable melt blended composition comprises that stablizing melt blended composition is exposed to gamma-rays, electron beam, X ray radiation, ethylene oxide gas to bear, and can not damage functional characteristic and/or the aesthstic attractive force of finished product.

According to an embodiment, provide the step of melt blended composition to comprise that one or more in charging recycled resin component and following component are to melt compounding extruder: filler component, surface modifier component, processing aid component and enhancer component are covered in antioxidant ingredients, slip agent component, antistatic additive component, anti-impact modifier component, coloring agent component, plumper component, melt blended material component, clarifier component, x-ray fluorescence agent component, radiation.The step of hardening composition comprises injection moulding composition, in extruding composition and rotational molding compositions one.

Described reclaimed resin composition, the medical device of being made by it and parts, and the method for preparing this medical device and parts provides a supply chain system unique, that reduce the impact on garbage loading embeading.

The present invention should further understand at the nonrestrictive embodiment by reference to below; But the scope of claim can not be limited thus.

Embodiment

Formula 1-6 of the present invention is by mechanical mixture recirculation acrylic resin and new acrylic resin preparation, and wherein new acrylic resin further comprises antioxidant, plumper and melt stability agent.

Formula 1 of the present invention comprises the recirculation polypropylene component A of 60 % by weight and the new polypropylene component A of 40 % by weight.New polypropylene component A comprises up to the antioxidant ingredients of 0.8 % by weight and melt stability agent component, and up to the plumper of 0.3 % by weight.

Formula 2 of the present invention comprises the recirculation polypropylene component B of 70 % by weight and the new polypropylene component A of 30 % by weight as above.

Formula 3 of the present invention comprises the recirculation polypropylene component C of 50% weight and the new polypropylene component A of 50 % by weight as above.

Formula 4 of the present invention comprises the recirculation polypropylene component A of 60 % by weight and the new polypropylene component B of 40 % by weight.New polypropylene component B comprises the antioxidant ingredients up to 0.3 % by weight, and up to the plumper component of 0.2 % by weight.

Formula 5 of the present invention comprises the recirculation polypropylene component B of 50 % by weight as above and the new polypropylene component B of 50 % by weight.

Formula 6 of the present invention comprises the recirculation polypropylene component D of 60 % by weight and the new polypropylene component A of 40 % by weight as above.

Carry out physical property analysis to every kind in formula 1-6 of the present invention.Particularly, evaluate flexural modulus, tensile yield strength, tensile break strength, tensile yield percentage elongation, tension fracture elongation rate, stretch modulus, Izod impact strength and the heat distortion temperature of formula 1-6 of the present invention and provide in following table 1.In order to compare, the typical range of the physical property of new polypropylene component provides in table 2.

Flexural modulus is measured according to ASTM D790-03.Five samples to every kind of formula 1-6 of the present invention are tested.On the equipment that test provides in New Jersey Rahway Instru-Met company, carry out with the crosshead speed of 0.05 inch per minute clock and the support span of 2 inches.Before testing, sample forms by injection-molded technique and 23 DEG C and 50% the lower adaptation of relative humidity (RH) 40 hours.The fill a prescription each average flexural modulus of five samples of the present invention is measured and is provided in table 1.

The fill a prescription tensile property of 1-6 of the present invention is measured according to ASTM D638-03.Five samples to every kind of formula 1-6 of the present invention are tested.On the equipment that test provides in New Jersey Rahway Instru-Met company, carry out with the crosshead speed of 2.0 inch per minute clocks.Before testing, use injection-molded technique to form model I tensile bars sample, and 23 DEG C and 50% the lower adaptation of relative humidity (RH) 40 hours.The measurement of each average tensile yield strength, tensile break strength, tensile yield percentage elongation, tensile fracture elongation rate and the stretch modulus of five samples of the present invention's formula provides in table 1.

The fill a prescription Izod impact strength of 1-6 of the present invention is evaluated according to ASTM D256-02.Ten samples of every kind to formula 1-6 of the present invention are tested.The fill a prescription measurement of average Izod impact strength of 1-6 of the present invention provides in table 1.

The present invention fill a prescription the heat distortion temperature of 1-6 according to ASTM D648-06, use available from pennsylvania, USA Horsham Tinius Olsen, the HDT/Vicat of Inc., under the load of 66psi, measure.The fill a prescription evenly heat deformation temperature of 1-6 of the present invention provides in table 1.

Table 1: the fill a prescription physical property of 1-6 of the present invention

Table 2: the representative physical properties of new vistanex

The physical property of formula 1-6 of the present invention is with suitable in the physical property of the new vistanex shown in table 2.Therefore, recycled resin compositions as herein described realized use bio-compatible and can apply useful recycled resin and not damage the object of the physical property of gained equipment for medical device.

Also analyze the biocompatibility of formula 1-6 of the present invention.Particularly, analyze every kind in formula 1-6 of the present invention according to ANSI/AAMI/ISO10-993-5 and American Pharmacopeia biological test and analysis, external biological reactivity test <87>.American Pharmacopeia in vitro biological reactivity test <87> is designed to determine biological reactivity, the direct or indirect patient's contact of described elastomer plastic or the specific extraction thing of being prepared by material under testing of mammalian cell cultures after contact with elastomer plastic and other polymeric materials.Formula 1-6 of the present invention is carried out in the American Pharmacopeia elution test that in vitro biological reactivity is described in testing <87>.

Every kind of formula of the present invention 1-6 with 0 point of American Pharmacopeia scoring by or meet cell toxicity test standard, meet thus the criterion of the clinical front toxicology safety evaluation of being set up by American Pharmacopeia and ISO10-993-5.All biocompatibility tests all carry out according to good laboratory specification (Good Laboratory Practice) or the GLP principle of following program known in the art.

Run through that this description is mentioned " embodiment ", " specific embodiment ", " one or more embodiment " or " embodiment " refers to that specific feature, structure, material or the characteristic described together with embodiment are contained at least one embodiments of the present invention.Therefore, may not refer to same embodiment of the present invention at the different local phrases that occur as " in one or more embodiments ", " in specific embodiment ", " in one embodiment " or " in embodiment " running through this description.In addition, specific feature, structure, material or characteristic can combinations in any suitable manner in one or more embodiments.

Although described invention herein with reference to specific embodiment, it should be understood that these embodiments only illustrate principle of the present invention and application.It will be apparent to those skilled in that and understand and can carry out various amendments and change to method of the present invention and equipment without departing from the spirit and scope of the present invention.Therefore, amendment and the change within the scope that is included into additional claims and equivalent thereof contained in the present invention.

Claims (20)

1. a syringe plunger rod, it comprises:

The main body of extending, it has near-end and the far-end of length of restriction, and the main body of described elongation is formed by one or more the compositions comprising in the stable recycled resin of sterilizing and bio-based compositions;

Finger pressure, it is positioned at the near-end of the main body of described elongation; With

Stopper eyelid retractor, it is positioned at the far-end of the main body of described elongation, and the main body of described elongation is formed by one or more in the stable recycled resin of sterilizing and bio-based compositions.

2. syringe plunger rod claimed in claim 1, the main body of wherein said elongation comprises at least one rib, and it extends the length of the main body of described elongation, and described at least one rib comprises the perforate at multiple intervals.

3. syringe plunger rod claimed in claim 2, the main body of wherein said elongation comprises the rib of four plus sige shapes.

4. syringe plunger rod claimed in claim 3, the perforate at wherein said multiple intervals is along two in described four ribs.

5. syringe plunger rod claimed in claim 2, the main body of wherein said elongation comprises three ribs.

6. syringe plunger rod claimed in claim 5, the perforate at wherein said multiple intervals is along two in three ribs.

7. syringe plunger rod claimed in claim 5, the perforate at wherein said multiple intervals is along one in described three ribs.

8. syringe plunger rod claimed in claim 2, further comprises along the supporting walls at the length interval of the main body of described elongation.

9. syringe plunger rod claimed in claim 2, the main body of wherein said elongation comprises the rib of two V-arrangements, and the supporting walls at the length interval of multiple main body along described elongation.

10. syringe plunger rod claimed in claim 2, the main body of wherein said elongation comprises at least two ribs of the length of the main body of extending described elongation, and the perforate at described multiple intervals is positioned at and is less than on all ribs.

11. syringe plunger rod claimed in claim 1, further comprise along multiple supporting walls at the length interval of the main body of described elongation.

12. syringe plunger rod claimed in claim 1, the main body of wherein said elongation comprises hollow bulb.

Syringe plunger rod described in 13. claim 11, at least one rib that is further included in described hollow bulb, extends along the length of the main body of described elongation at least in part.

Syringe plunger rod described in 14. claim 11, wherein said hollow bulb is configured as the shape of the main body that is substantially similar to described elongation.

15. syringe plunger rod claimed in claim 1, wherein said compositions further comprises one or more in following component: filler component, surface modifier component, processing aid component, melt stability agent, clarifier and enhancer component are covered in antioxidant ingredients, slip agent component, antistatic ingredient, anti-impact modifier component, coloring agent component, plumper component, XRF agent component, radiation.

16. syringe plunger rod claimed in claim 1, the main body of wherein said elongation is cylindrical and runs through the main body of elongation, is separated with multiple perforates along between the length of described elongation main body.

17. 1 kinds of syringe plunger rod, it comprises:

The main body of extending, it has the near-end and the far-end that limit length, and the main body of described elongation has at least one perforate that runs through it;

Finger pressure, it is positioned at the near-end of the main body of described elongation; With

Stopper eyelid retractor, it is positioned at the far-end of the main body of described elongation,

Wherein said plunger rod is manufactured by one or more the compositions comprising in new material, sterilizing stable recycled resin and bio-based compositions.

Syringe plunger rod described in 18. claim 17, the main body of wherein said elongation comprises at least one rib of the length of the main body of extending described elongation, and along multiple perforates at the length interval of described at least one rib.

Syringe plunger rod described in 19. claim 17, the main body of wherein said elongation comprises along the hollow bulb of the length of the main body of described elongation.

Syringe plunger rod described in 20. claim 19, at least one rib that is further included in described hollow bulb, extends along at least part of length of the main body of described elongation.